| Device Type ID | 5616 |
| Device Name | Catheter, Irrigation |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5616 |
| Device | Catheter, Irrigation |
| Product Code | GBX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| CFR Regulation Number | 878.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MOERAE MATRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 58 |
Material Separation | 23 |
Crack | 20 |
Fracture | 16 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Fluid Leak | 11 |
Misassembled | 8 |
Defective Component | 7 |
Disconnection | 7 |
Device Contamination With Chemical Or Other Material | 6 |
Occlusion Within Device | 6 |
Tear, Rip Or Hole In Device Packaging | 5 |
Material Deformation | 5 |
Leak / Splash | 4 |
Kinked | 4 |
Detachment Of Device Or Device Component | 4 |
Difficult To Remove | 4 |
Unraveled Material | 4 |
Delivered As Unsterile Product | 4 |
Disassembly | 4 |
Suction Problem | 3 |
Material Frayed | 3 |
Device Operates Differently Than Expected | 3 |
Device Operational Issue | 3 |
Material Twisted / Bent | 3 |
Material Integrity Problem | 3 |
Torn Material | 3 |
Device Damaged Prior To Use | 3 |
Restricted Flow Rate | 2 |
Difficult To Insert | 2 |
Packaging Problem | 2 |
Difficult To Position | 2 |
Split | 2 |
Aspiration Issue | 2 |
Separation Failure | 2 |
Material Fragmentation | 2 |
Migration Or Expulsion Of Device | 2 |
Physical Property Issue | 2 |
Appropriate Term/Code Not Available | 2 |
Catheter | 1 |
Obstruction Of Flow | 1 |
Activation, Positioning Or Separation Problem | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Balloon | 1 |
Circuit Failure | 1 |
Contamination / Decontamination Problem | 1 |
Cannula | 1 |
Burst Container Or Vessel | 1 |
Suture | 1 |
Guidewire | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Hole In Material | 1 |
Cylinder | 1 |
Tube | 1 |
Ring | 1 |
Device Handling Problem | 1 |
Wire(s), Breakage Of | 1 |
Detachment Of Device Component | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Defective Device | 1 |
Nonstandard Device | 1 |
Needle | 1 |
Loose Or Intermittent Connection | 1 |
Dull, Blunt | 1 |
Device Markings / Labelling Problem | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Connector Pin | 1 |
Component Falling | 1 |
| Total Device Problems | 290 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cardinal Health 200, LLC | II | Jul-18-2018 |
| 2 | Cardinal Health 200, LLC | II | May-23-2017 |
| 3 | Degania Silicone, Ltd. | III | Feb-20-2018 |
| 4 | Degania Silicone, Ltd. | II | Feb-22-2017 |
| 5 | Hospira Inc. | II | May-16-2014 |